Join this group of domestic and international attendees as they gather in Boston to hone their practice and to hear from a stellar faculty, led by a “who’s who” of the nation’s food and drug lawyers, to help understand:
- The application and approval processes for drugs, biologics, and devices
- The regulatory balance between brand name and generic products
- The complexities of the patent and IP landscape, including Hatch- Waxman, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA and 505(b)(2)
- The pivotal role of labeling in the drug and biologics approval process
- The importance of cGMPs to the post-approval regulatory process
- Advertising and Promotion, DTC Advertising, & Off-Label
- The protocols of adverse events monitoring, pharmacovigilance, and REMS
- Non-patent exclusivity, bioequivalency, and Follow-On Biologics
- Recalls, product withdrawals, and FDA oversight authority
Kurt Karst, a Director at Hyman, Phelps & McNamara, P.C., will be a co-chair of the event and explains why FDA Boot Camp has remained such a draw for a decade:
“ACI’s FDA Boot Camp is the premiere conference for learning about the basics and the ins and outs of food and drug law. Attendees have the opportunity to interact with thought leaders in the food and drug law field, and to ask those burning questions they always wanted to ask about some rather complex topics. The goal is to leave ACI’s FDA Boot Camp with a solid FDA understanding from which you can add value to your company or clients.”
Daniel Kracov, a partner at Arnold & Porter LLP will join Kurt as a co-chair and agrees:
“This conference is a great opportunity to quickly get up to speed on the framework for FDA regulation of drugs and devices. The faculty of experienced FDA legal practitioners knows how to explain critical and complex FDA processes, standards and concepts in an understandable way, and attendees will be able to immediately utilize this knowledge on a day-to-day basis. If you want to gain comprehensive knowledge in this area in a very efficient way, this course is the perfect opportunity.”
Other program highlights include special tracks for patent litigators and product liability lawyers. Save the phone calls to your colleagues or other regulatory counsel for the truly complicated issues; attend ACI’s FDA Boot Camp to boost your regulatory IQ.
To learn more, visit: http://www.americanconference.com/
About American Conference Institute
A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.
Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.
212.352.3220 x 5235
212.352.3220 x 5235